最新刊期
卷 46 ， 期 10 ， 2021
- 摘要：OBJECTIVE：To identify and evaluate the risk factors of innovative drug clinical trials ，and to provide references for the development of risk management and control strategies. METHODS ：Using the method of literature research ，the risk factors of innovative drug clinical trials were obtained ，classified and sorted out ，and the risk evaluation indicators were initially formed. On this basis ，the questionnaire was designed. By means of interview and questionnaire survey ，54 experts were invited from 4 tertiary hospitals and 1 contract research organization to score. SPSS 24.0 software was used to perform principal component analysis on risk event status data. RESULTS & CONCLUSIONS ：The risk evaluation system included 9 first-class indicators such as policy and legal risk ，clinical trial institution risk and trial scheme design risk ，and 31 second-class indicators such as industrial policy，law and regulation changes ，intellectual property risk . According to the analysis ，the risk factors of innovative drug clinical trials mainly included drug and biological sample management risk ，trial scheme design risk ，clinical trial institution risk ，safety report management risk ，ethical review risk ，policy and legal risk ，and subject management risk. Relevant parties in clinical trials need to focus on monitoring various risk factors ，establish dynamic monitoring and control mechanism and implementation guarantee mechanism ，and effectively prevent and control risk ，to promote the smooth implementation of clinical trials.
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To understand the current situation and existing problems of Blumea balsamifera industry in China ， and to provide reference for its sustainable development . METHODS ：With the keywords of “B. balsamifera ”“Ai Pian ”“Ai Fen ”， etc.，through the patent platform of SooPat and Baiten ，the patent data of B. balsamifera that had been published from Jan. 1989 to Dec. 2019 were collected. The International Patent Classification （IPC）was used to sort out and count the patent information of B. balsamifera，to understand the development status of B. balsamifera industry in technology and research field ，to analyze the existing problems and to explore the development trend of B. balsamifera industry in China so as to put forward corresponding suggestions. RESULTS & CONCLUSIONS：A total of 690 patents related to B. balsamifera were collected ，mainly invention patents，of which the authorization rate was 27.39％，the effective rate was 17.97％，and the failure rate was 55.22％. Top 10 applicants with the largest number of applications had a total of 165 applications，accounting for 23.91％ of the total number of applications. Top 10 applicants were 4 enterprises，3 natural persons and 3 colleges and universities. The patents of B. balsamifera were mainly distributed in Guizhou ，Shandong，Anhui，Guangdong，Guangxi and Hainan ，accounting for 81.01％ of the total patent applications of B. balsamifera . The patent technology field of B. balsamifera had expanded from traditional Chinese medicine to daily chemical products ，health care and physiotherapy and other daily consumer good fields. From the perspective of patent intensity，the number and quality of patent applications were not coordinated ，and there were many meaningless patent applications，and the conversion rate was low. It is suggested that China should strengthen the research on B. balsamifera and its more compatible medicinal materials ，promote the innovation ，development，transformation and upgrading of B. balsamifera industry；strengthen the systematic and in-depth research on B. balsamifera，improve the quality and conversion rate of patent xiexiaoli13@126.com technology，and revitalize the development of B. balsamifera industry； expand multi-party cooperation ， strengthen the E-mail：fulai.yu@163.com research on patent core technology ，build the strategic alliance of intellectual property rights of B. balsamifera industry，and realize the high quality development of B. balsamifera industry.关键词：Blumea balsamifera;Patent analysis;Industry development;SooPat platform;Baiten platform
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To provid e reference for promoting the application of real-world evidence in pediatric medical product R&D. METHODS ：The progress of real-world evidence in pediatrics in the United States and Europe was introduced. The obstacles of real-world evidence in pediatric drug R&D were analyzed ，and a series of feasibility suggestions were put forward. RESULTS & CONCLUSIONS：Real world evidence had been widely used in pediatric medical product R&D ，including evaluation and validation of biomarkers and prognostic indicators ，clinical trial design and optimization ，support for extended indications ， post-marketing safety monitoring/pharmacovigilance ，etc. There were still many obstacles ，such as data fragmentation and access restrictions，lack of standardized analysis methods for real-world evidence ，lack of key pediatric variables ，and difficulties in obtaining informed consent from pediatric patients. In order to promote the application of real-world evidence in pediatrics ，it is suggested to strengthen the construction of data infrastructure ，expand the application of general data model ，develop methods for collecting longitudinal data of pediatric patients ，and carry out reasonable research design.关键词：Real-world evidence;Pediatric;Medical product;R&D;Challenges
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To prepare paclit axel and schisandrin B liposomes modified by cell penetrating peptide RPV ，and to preliminarily evaluate its anti-tumor activity in vitro . METHODS ：RPV modified paclitaxel and schisandrin B liposomes were prepared by film dispersion method. Box-Benhken design-response surface methodology was used to optimize the prescription technology of RPV modified paclitaxel and schisandrin B liposomes using the amount of cholesterol and paclitaxel ，the time interval of ultrasound probe as factors ，average entrapment efficiency of paclitaxel and schisandrin B was used as the index. The liposomes prepared by the optimal technology were characterized. Sulfonylrhodamine B staining method was used to investigate in vitro toxicity of RPV modified blank liposomes ，paclitaxel and schisandrin B liposomes ，RPV modified paclitaxel and schisandrin B liposomes to human ovarian cancer cell SK-OV- 3. The effects of 3 kinds of liposomes on the migration and invasion ability of SK-OV-3 cells were investigated by cell scratch test and Transwell chamber invasion test. RESULTS ：The optimal prescription technology was phospholipid 44 mg，cholesterol 8 mg，paclitaxel 0.64 mg，schisandrin B 1.5 mg，ultrasonic probe time interval 5 s，prescription dosage 5 mL. According to the optimal prescription technology ，the liposomes were spherical in shape ，and the particle size was （126.49±1.19）nm，Zeta-potential was （－4.83±0.61）mV，average entrapment efficiency of liposomes was （93.88±1.67）％. Compared with RPV modified blank liposomes ，after treated with paclitaxel and schisandrin B liposomes and RPV modified paclitaxel and schisandrin B liposomes ，the survival rate ，migration inhibition rate and invasion rate of SK-OV- 3 cells were significantly decreased （P＜0.05）. The effects of RPV modified paclitaxel and schisandrin B liposomes was better than those of paclitaxel and schisandrin B liposomes （P＜0.05）. CONCLUSIONS ：RPV modified paclitaxel and schisandra B liposome are successfu lly prepared ，and they have certain antitumor activity in vitro .
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To study the improvement effects of sinapic acid （SA）on PC 12 cell damage induced by Aβ1-42，and to investigate its effect on brain-derived neurotrophic factor （BDNF）/tyrosine kinase B （TrkB）/extracellular signal-regulated kinase （ERK）signaling pathway. METHODS ：PC12 cells were divided into blank group ，model group ，SA low-dose and high-dose groups（50，100 μmol/L）. Except for blank group ，cell damage was induced by Aβ1-42 in other groups ；24 h after modeling ， administration groups were added with the corresponding solution and cultured for 24 h. Morphological changes of cells in each group were observed. Cell survival rate ，mRNA expression and protein level of BDNF ，protein expression of TrkB ，ERK1/2 and phosphorylated ERK 1/2（p-ERK1/2）were detected. p-ERK/ERK ratio was calculated. RESULTS ：Compared with blank group ，the model group had shorter synapses ，looser intercellular junctions ，poor adhesion ，dim cytoplasm and more granules in cytoplasm. Cell survival rate and mRNA expression and protein level of BDNF ，the relative expression of TrkB and p-ERK 1/2 protein，p-ERK/ ERK ratio were significantly decreased （P＜0.05 or P＜0.01）. Compared with model group ，in SA high-dose group the pathological changes of the cells were significantly improved ，the survival rate of the cells ，the mRNA expression and protein level of BDNF，the relative expression of TrkB and p-ERK 1/2 protein， p-ERK/ERK ratio were significantly increased （P＜0.05 or P＜ 0.01）. CONCLUSIONS：SA can i mprove PC 12 cells damage induced by Aβ1-42，the mechanism of which may be associated with activating BDNF/TrkB/ERK signaling pathway. qq.com
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To preliminarily s tudy the potential mechanism of astragaloside Ⅳ on allergic rhinitis （AR）model mice. METHODS ：C57/BL6 mice were randomly divided into blank group ，model group and astragaloside Ⅳ group，with 10 mice in each group. Except for blank group ，AR model was prepared by sensitization and challenge with ovalbumin on day 0，7，14 and 21-27. Astragaloside Ⅳ group was given astragaloside Ⅳ 40 mg/kg intraperitoneally at the dose of 0.02 mL/g on the 15th to 27th day of modeling （given the drug 1 h before challenge sensitization on the 21st to 27th day ）. Blank group and model group were given constant volume of normal saline intraperitoneally ，once a day. Twenty-four hours after sensitization from the last challenge ， the infiltration of inflammatory cells in the nasal mucosa of each group was observed ，and the contents of interleukin 4（IL-4）， IL-5 and interferon gamma （IFN-γ）in the nasal lavage fluid were measured. The levels of reactive oxygen species （ROS），and the count of phosphorylated Janus kinase 2（p-JAK2）and phosphorylation signal transduction and activation of transcription protein 6 （p-STAT6）positive cells in the nasal mucosa and spleen as well as the phosphorylation levels of JAK 2 and STAT 6 proteins in spleen tissue （i.e. p-JAK 2/JAK2 ratio，p-STAT6/STAT6 ratio）were also determined. RESULTS ：Compared with blank group ，the number of inflammatory cells in the nasal mucosa （eosinophils and mast cells ）in the model group ，the contents of IL- 4 and IL- 5 in the nasal lavage fluid ，and the levels of ROS in the nasal mucosa and spleen tissues in the model group ，the count of p-JAK 2 and p-STAT 6 positive cells increased significantly ，the p-JAK2/JAK2 ratio，p-STAT6/STAT6 ratio in the spleen tissue were significantly increased （P＜0.05），and the content of INF-γ in the nasal lavage fluid was significantly decreased（P＜0.05）. Compared with model group ，the count of inflammatory cells infiltrated in the nasal mucosa ，the contents of IL- 4 and IL- 5 in the nasal cavity lavage fluid ，the level of ROS and the number of p-JAK 2 and p-STAT 6 positive cellsin the nasal mucosa and spleen tissue as well as the p-JAK2/JAK2 ratio and p-STAT 6/STAT6 ratio in spleen tissue were decreased significantly （P＜0.05），and the content of INF-γ in nasal lavage fluid was significantly increased（P＜0.05）. CO NCLUSIONS：Astragaloside Ⅳ can effectively improve the inflammatory response in AR model mice ，the mechanism of which may be related to down-regulation of JAK2/STAT6 signaling pathway and ROS level.
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To study the inhibi tory effects of genistein on the growth of human nasopharyngeal carcinoma. CNE 1 cells and predict its potential target. METHODS ：CCK-8 method was used to test the effects of 0（blank control ），12.5，25，50， 100，150 µmol/L genistein on the proliferation of CNE 1 cells after treated for 24，48，72 h. Flow cytometry was carried out to detect the effects of 0（blank control ），15，30，60 µmol/L genistein on the cell cycle and ap optosis of CNE 1 cells after treated for 24 h. Scratch test was used to investigate the effects of 0（blank control ）， 10， 20， 30 µmol/L genistein on themigration ability of CNE 1 cells after treated for 24 h. High （No.18210156） throughput sequencing was conducted to discover the differential genes in CNE 1 cells after treated with 0（blankcontrol），30 µmol/L genistein for 24 h. RT-qPCR assay was adopted to verify the mRNA expression of related differential genes in above trials. RESULTS ： Compared with blank control，12.5，25，50，100，150 µmol/L genistein sho wed significant inhibitory effect on the proliferation of CNE 1 cells（P＜ 0.01），in a concentration- time-effect manner ；15，30 µmol/L genistein could arrest CNE 1 cell cycle at G 0/G1 stage（P＜0.05 or P＜ 0.01）；30，60 µmol/L could arrest CNE 1 cell cycle at G 2/M stage and promoted cell apoptosis （P＜0.05 or P＜0.01）. 10，20，30 µmol/L genistein could significantly inhibit the migration ability of CNE 1 cells（padj＜0.01）. High throughput sequencing revealed a total of 2 271 differentialgenes（P＜0.05），1 154 of which were up-regulated while 1 117 of which were down-regulated ；8 potential target genes ，including p53，p21，STC2，FGF2，CDK6，CYCLIN D ，PI3K，AKT，were screened by cell experiment. After validated by RT-qPCR assay ，mRNA expression of p53，p21，STC2，FGF2，CDK6，CYCLIN D and AKT were significantly down-regulated（P＜0.05），which consistent with the sequencing results. CONCLUSIONS ：Genistein can effectively inhibit the growth of human nasopharyngeal carcinoma CNE 1 cells，the mechanism of which may associated with inhibiting the expression of mutant gene p53，restoring the function of wild-type P 53 protein and inhibiting the activity of PI 3K/Akt pathway.关键词：Genistein;Human nasopharyngeal carcinoma CNE 1 cells;High throughput sequencing;Mutant gene p53;PI3K/
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To compare the chemical constituents of petroleum ether fraction from ethanol extract of Aconitum sinomontanum before and after processing. METHODS ：After A. sinomontanum was purified with water ，the raw product decoction pieces were prepared ；the raw decoction pieces were steamed with licorice juice under high pressure to prepare processed decoction pieces of A. sinomontanum . The petroleum ether fractions of raw product and processed product were obtained after ultrasonic extraction with 95％ ethanol. The chemical constituents in the samples were analyzed by GC-MS. NIST 2014 mass spectrometry database was used to compare and match the components . The peak area normalization method was used to determine the relative percentage content of each component. RESULTS ：Before and after processing ，fatty acids and esters were the main components in the petroleum ether fraction from ethanol extract. Totally 18 chromatographic peaks were detected in the detection pieces of raw product，and 13 compounds were identified ，accounting for 94.60％ of the total content of volatile components. The components with relatively high content were （Z，Z，Z）-9，12，15-octadecatrienoic acid （26.13％），hexadecanoic acid ethyl ester （25.27％）， palmitoleic acid （10.84％），ethyl linoleic acid （10.67％），（Z，Z）-9，12-octadecenoic acid methyl ester （6.66％），pentadecanoic acid（5.11％）and so on. Totally 25 chromatographic peaks were detected in the decoction pieces of processed products，and 18 components were identified ，accounting for 82.40％ of the total content of volatile components. The components with relatively high content were palmitoleic acid （18.95％），（Z，Z）-9，12-octadecenoic acid methyl ester （17.93％），hexadecanoic acid ethyl ester（11.94％），（Z，Z，Z）-9，12，15-octadecatrienoic acid （10.54％），（Z，Z）-9，12-octadecenoic acid （5.51％），（Z）-11-hexadecanoic acid（5.30％）and so on. After processing ，7 new components were added ，5 of which were identified as （－）-eucalyptus globulus alcohol，ethyl 2-methyltetrade-canoate，6-methyl-4-phenylcoumarin，β-sitosterol，heptadecane. After processing ，no components disappeared，and the content of some components increased or decreased. CONCLUSIONS ：After processing ，the volatile components in the petroleum ether fraction from ethanol extract of A. sinomontanum are different ，and（－）-eucalyptus globulus alcohol and other components are added after processing.关键词：Aconitum sinomontanum;Processing;Ethanol extract;Petroleum extraction fraction;GC-MS;Chemical
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发布时间：2022-06-21 - 摘要：OBJECTIVE： To study the tonifying spl een effect of Codonopsis pilosula polysaccharides （CPP） on spleen-deficiency model mice. METHODS ：Totally 60 ICR male mice were randomized into blank group ，model group ，CPP high-dose，medium-dose and low-dose groups [ 1.6，0.8，0.4 g/（kg·d）]，Sijunzi tang （SJZT）group [ 30 g/（kg·d），by crude drug] ， with 10 mice in each group. Except for blank group ，other groups were given Sennae Folium solution intragastrically （0.4 g/d）to establish spleen-deficiency model. After modeling ，administration groups were given relevant drug intragastrically ，and blank group and model group were given 20 mL/kg normal saline intragastrically ，once a day ，for consecutive 6 weeks. After last administration，body weight of mice in each group was measured and their general behavioral characteristics were observed. The red blood cell count in whole blood were recorded ，and the contents of D-xylose，gastrin（GAS），motilin（MTL），somatostatin （SS），vasoactive intestinal peptide （VIP），amylase（AMS），immunoglobulin（IgG and IgM ）and lipopolysaccharide （LPS）in serum were determined ；mRNA and protein expressions of Claudin and Occludin in colon tissues of mice were also detected. RESULTS：Compared with blank group ，body weight of mice in model group was significantly decreased （P＜0.05），and the spleen deficiency symptoms such as sparse back hair and no luster appeared ；the red blood cell count in whole blood ，serum contents of D-xylose，SS，VIP，AMS，IgG and IgM ，mRNA and protein expressions of Claudin and Occludin were significantly decreased（P＜0.05 or P＜0.01）；serum contents of GAS ，MTL and LPS were significantly increased （P＜0.01）. Compared with model group ，the body weight of mice were increased significantly in CPP high-dose group （P＜0.05），and spleen-deficiency symptom was improved significantly. Except for the serum contents of D-xylose and IgM ，the protein expressions of Claudin and Occludin in colon tissue had no statistical significance in CPP low-dose group （P＞0.05），above indexes of other groups w ere improved significantly （P＜0.05 or P＜0.01）. CONCLUSION ：CPP can i mprove spleen-defic iency model mice induced by Sennae Folium，the mechanism of which may be associated with regulating gastrointestinal hormone secretion ， enhancing immunity and protecting intestinal mucosal barrier.
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To predict the potenti al target and mechanism of Astragali Radix in the treatment of ulcerative colitis （UC），and to provide reference for the clinical application of Astragali Radix in the treatment of UC. METHODS ：The active components and their corresponding target genes of Astragali Radix were retrieved by TCMSP and UniProt KB database.related target genes of UC were searched by Gene Cards GZK-2018-5） database. The intersection target genes of Astragali Radix and were obtained by Venny 2.1.0 online mapping tool ，and interaction network of “drug-compound-intersection target ” was constructed by using Cytoscape 3.7.0 software. PPI network of intersecting targets was obtained by using STRING 结合动物模型。E-mail：172924249@qq.com database， and the visualization analysis and topological analysis w ere carried out by using Cytoscape 3.7.0 software to obtain the core target genes. By using DAVID database ，the gene ontology （GO） function annotation and KEGG pathway enrichment of intersecting target genes were carried out ，and the “target-pathway”enrichment network was constructed by using Cytoscape 3.7.0 software. Through Auto Dock vina 1.1.2 software， the top five active components in the list of degree value were linked with the protein encoded by the core target genes ；Discovery Studio 3.5 software was applied to draw out binding pattern map. RESULTS ：There were 143 compounds in Astragali Radix ，20 active components were screened out ，and 189 corresponding target genes were selected ；there were 4 356 UC disease related target genes. There were 126 intersection target genes of Astragali Radix （involving 14 active components ）and UC. The core target genes in PPI network were AKT1，MAPK1，RB1，JUN，etc. A total of 2 294 GO items （q value＜0.05）were obtained from GO functional annotation ，including 2 093 biological process items （e.g. response to lipopolysaccharide ，response to molecule of bacterial origin ），49 cell composition items （e.g. membrane raft ，membrane microdomain ），and 152 molecular function items （e.g. nuclear receptor activity ，ligand-activated transcription factor activity ）. KEGG pathway enrichment analysis yielded 160 items（q value＜0.05），such as fluid shear stress and atherosclerosis signaling pathway ，phosphatidylinositol 3 kinase/protein kinase B （PI3K/Akt） signaling pathway ，interleukin-17 （IL-17） signaling pathway. Molecular docking results showed that top 5 active ingredients （quercetin，kaempferol，formenonetin，isorhamnetin，7-O-methylisomucronulatol） in the list of degree value had binding energies ＜5.0 kcal/mol with the protein encoded core targets. CONCLUSIONS ：Quercetin，kaempferol，formononetin and other active components in Astragali Radix may play a role in the treatment of UC through the action of MAPK14，JUN，AKT1 and other target genes ，and then on the signal pathways such as PI 3K/Akt and IL- 17.关键词：Astragali Radix;Active ingredients;Ulcerative colitis;Network pharmacology;Molecular docking;Mechanism
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To provide reference for the quality control of the leaves of Toricellia angulata . METHODS ：HPLC method was adopted. The determination was performed on Agela Promosil C 18 column with 0.2％ phosphoric acid solution-acetonitrile（gradient elution ）as mobile phase at the flow rate of 1.0 mL/min. The detection wavelength was set at 210 nm，and column temperature was 35 ℃. The sample size was 10 μL. HPLC fingerprint of 10 batches of the leaves of T. angulata was established and similarity evaluation was conducted by using Similarity Evaluation System of TCM Chromatographic Fingerprint（2004 edition）. The chromatographic peak was identified by comparing with the chromatogram of reference substance. Cluster analysis ，PCA and PLS-DA were used to identify chemical patterns ，and the quality differential markers were screened. The contents of hyperoside and isoquercitrin were determined by the same HPLC. RESULTS ：The similarities of HPLC fingerprint of 10 batches of the leaves of T. angulata with control fingerprint were 0.923-0.983. A total of 11 common peaks were identified ，and the peaks 4 and 5 were hyperoside and isoquercitrin ，respectively. Results of cluster analysis ，PCA and PLS-DA showed that 10 batches of leaves of T. angulata could be divided into two categories ，Y10 was clustered into one category ，and others were clustered into one category. PLS-DA analysis showed that 6 common peaks （peaks 4，3，10，2，6 and 11） with variable importance projection （VIP）greater than 1 were selected. Average contents of hyperoside and isoquercitrin in 10 batches of the leaves of T. angulata were 0.47-6.97，0.21-1.87 mg/g，respectively. CONCLUSIONS ：Established HPLC fingerprint and the method for content determination are stable and reliable ，and can be used for the quality control of the leaves of T. angulata from different areas. Six quality differential markers including hyperoside in the leaves of T. angulata from different areas are qnyz202034） preliminarily screened.
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To investigate the compatibility stability of Calcium gluconate injection with different solvents within 24 h，and to provide reference for clinical drug use. METHODS ：10％ Calcium gluconate injection was mixed with 0.9％ Sodium chloride injection and 5％ Glucose injection in the proportion of 10∶100，30∶100 and 50∶100（v/v）as trial group ，and mixed with 10％ Glucose injection in the same proportion as control group. The water was mixed with 0.9％ Sodium chloride injection ，5％ Glucose injection and 10％ Glucose injection in the same proportion as the blank control group. The appearance of the infusion in the trial group and the control group was observed within 24 h after preparation. pH value and the number of insoluble particles were detected and compared with the blank control group. The content of 5-hydroxymethylfurfural and the change of UV absorption spectrum were determined by UV spectrophotometry. RESULTS ：Compared with the blank control group infusion at the same time ， the infusion of trial group and the control group were colorless ，clear solution ，no visible foreign body ，and the pH value of the infusion of trial group and the control group had no significant change within 24 h. Within 24 h after preparation ，the number of insoluble particles ≥10 and ≥25 μm in 3 groups fluctuated but met the pharmacopoeia standard ；the number of insoluble particles with small particle size （5-10 μm）increased slightly with time ，but there was no significant difference between trial group ，control group and blank control group. The linear range of 5-HMF was 0.149-4.751 μg/mL（R2＝0.999 9）；the limit of quantitation was 0.013 μg/mL；RSDs of precision ，repeatability and stability tests （24 h）were less than 2％；average recovery was 105.23％ （RSD＝1.08％，n＝9）. The content of 5-HMF and the UV absorption spectrum had no significant change in 2 groups within 24 h. The absorbance of UV measured at 284 nm was in line with the pharmacopeia. CONCLUSIONS ：Calcium gluconate injection ， 0.9％ Sodium chloride injection and 5％ Glucose injection have good stability within 24 h，and can be used according to clinical needs.关键词：Calcium gluconate injection;Solvent;Stability;Compatibility
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To establish the fingerprint of Jingu tongxiao pill ，and to determine the contents of 7 components. METHODS：HPLC method was adopted. The determination was performed on Cosmosil 5C18-MS-Ⅱ column with acetonitrile- 0.02％ phosphoric acid solution as mobile phase （gradient elution ）at the flow rate of 1.0 mL/min. The detection wavelength was 230 nm and the column temperature was set at 25 ℃. The sample size was 10 μL. HPLC fingerprint of 10 batches of Jingu tongxiao pill was established by using Similarity Evaluation System of TCM Chromatographic Fingerprint （2012 edition），and common peak was identified by comparing with the mixed reference substance. The contents of corresponding components of the identified common peak were determined by the same HPLC method. RESULTS ：There were 20 common peaks in HPLC fingerprint of 10 batches of samples ，and the similarity with the control fingerprint was not less than 0.980. By comparing with the mixed reference substance， 7 components were identified ， which were loganic acid ，gentiopicroside，paeoniflorin，salvianolic acid B ， cryptotanshinone，tanshinone Ⅰ and tanshinone Ⅱ A. The linear range of the above 7 components were 4.509-45.090， 15.090-150.900，14.985-149.850，14.982-149.820，2.967-29.670，1.944-19.440，3.094-30.940 μg/mL（all r＞0.999），respectively. The limits of detection were 0.060 1，0.161 0，0.399 6，0.159 8，0.031 6，0.051 8，0.082 5 μg/mL，respectively. The limits of quantitation were 0.200 4，0.503 0，0.999 0，0.399 5，0.079 1，0.259 2，0.412 6 μg/mL，respectively. RSDs of precision ，stability （24 h） and reproducibility tests were all lower than 3.0％ （n＝6）. Average recoveries were 98.81％ -100.28％ ，RSDs were 0.20％-1.21％（n＝6）. In 10 batches of samples ，the contents of the above 7 components were 0.441 0-0.969 4，3.283 4-4.733 4， 1.947 7-3.674 9，1.336 6-2.270 9，0.293 2-0.372 1，0.190 2-0.293 9 and 0.352 8-0.518 8 mg/g，respectively. CONCLUSIONS ：In this study，HPLC fingerprint and content determination method of Jingu tongxiao pill are successfully established and can be used for quality control.关键词：Jingu tongxiao pill;Fingerprint;Content determination;HPLC
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To st udy the effects of α7 nicotinic acetylcholine receptor agonists （PNU282987）on improving cardiac remodeling of mice and Janus kinase 2/signal transducer and activator of transcription 3（JAK2/STAT3）signaling pathway. METHODS：Male Kunming mice were randomly divided into normal control group ，model group ，propranolol group （positive control，i.g. 40 mg/kg）and PNU 282987 low-dose，medium-close and high-dose groups （intraperitoneal injection of 0.5，1.0，3.0 mg/kg），with 10 mice in each group. Except for the normal control group ，mice in the other groups were given isoproterenol （ISO，30 mg/kg） subcutaneously for 7 days to induce the cardiac remodeling model. After 30 minutes of ISO injection ， administration groups were given relevant liquid ，once a day ，for 7 consecutive days. Twelve hours after last administration ，the left ventricular ejection fraction （EF）and left ventricular short axis shortening rate （FS）of mice in each group were measured ，and the whole heart mass index （HMI）was calculated ；the pathological changes of myocardium were observed. The serum contents of lactate dehydrogenase （LDH），creatine kinase （CK），tumor necrosis factor α（TNF-α），interleukin 6（IL-6），the protein expression of intercellular adhesion molecule 1（ICAM-1）and adhesion molecule 1（VCAM-1）were also determined. The ratios of p-JAK2/JAK2，p-STAT3/STAT3 in myocardial tissue were detected. RESULTS ：Compared with normal control group ，EF and FS of model group were significantly reduced ，HMI，the contents of LDH，CK，TNF-α and IL-6，the protein expression of ICAM- 1 and VCAM- 1，the ratio of p-JAK 2/JAK2 and p-STAT 3/STAT3 were increased significantly （P＜0.05 or P＜0.01）； blue collagen deposition in the interstitium of myocardium was obvious，and the degree of fibrosis was severe. Compared with model group ， the EF and FS of the mice in the medium-dose and high-dose groups were increased significantly ， HMI （except for PNU 282987 medium-dose group ），the contents of LDH （except for PNU 282987 medium-dose group ），CK，TNF-α and IL-6，the protein expression of ICAM- 1 and VCAM- 1，the ratio of p-JAK 2/JAK2 and p-STAT 3/STAT3 were decreased significantly （P＜0.05 or P＜ 0.01）；blue collagen deposition in the myocardial interstitium was significantly reduced ，and the degree of myocardial fibrosis was significantly reduced. There was no significant difference in the comparison of the above indicators in PNU 282987 low-dose group （P＞0.05）. CONCLUSIONS ：PNU282987 can improve cardiac remodeling of mice ，the mechanism of which may be associated with inhibiting JAK 2/STAT3 signaling pathway.关键词：PNU282987;Isoproterenol;Cardiac remodeling;Anti-inflammatory effect;JAK2/STAT3 signaling pathway;Mice
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To evaluate the economy of pe rospirone in the treatment of schizophrenia ，to provide guidance for clinically proper use of medications more cost-effectively ，and related health decision-making . METHODS ：A short-term decision tree model was constructed from the perspective of medical insurance payer to calculate the cost and health outcomes of different treatment plans considering major adverse events including extrapyramidal reaction ，weight gain ，diabetes，hyperlipidemia. The cost-utility of perospirone were compared with quetiapine ，aripiprazole and olanzapine respectively ，using QALYs as the measure of health outcomes ，3 times GDP per capita as the willingness-to-pay threshold ；probability sensitivity analysis was performed. RESULTS：The results of base-case analysis showed that the cost of perospirone （6 688.25 yuan）was lower than those of quetiapine （9 887.45 yuan），aripiprazole（13 284.65 yuan）and olanzapine （15 332.80 yuan）. The utility of perospirone （0.79 QALYs）was better than those of quetiapine （0.76 QALYs），aripiprazole（0.77 QALYs）and olanzapine （0.75 QALYs）. Compared with quetiapine ， aripiprazole and olanzapine ，peropirone had lower cost and higher health outcome ，which indicated that strong dominance favors perospirone over the other 3 drugs. The results of sensitivity analysis were consistent with those of base-case analysis. CONCLUSIONS：Perospirone has economic advantages in treating schizophrenia patients compared to other commonly used atypical antipsychotic drugs.关键词：Schizophrenia;Perospirone;Decision tree model;Cost-utility analysis;Pharmacoeconomic evaluation
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To establ ish artificial neural netw orks（ANN）model to predict the interferon in the treatment of chronic hepatitis B （CHB），and to provide evidence for selecting suitable CHB therapy plan in clinic. METHODS ：The clinical data of 92 CHB patients treated by interferon ，from Guangzhou Eighth People ’s Hospital were retrospectively analyzed from Jul. 2011 to Dec. 2019. The basic information ，biochemical indexes ，blood routine indexes and virological markers of patients were collected. According to the effect of interferon ，the patients were divided into response group （73 cases）and non-response group （19 cases）. Minitab 18.0 software was used for multivariate Logistic regression analysis to screen the factors influencing the efficacy of interferon. Neurosolutions 5.0 software was used to randomly select 30％ of patients with CHB （27 cases）as the test group to establish and verify the ANN model. RESULTS ：The mean platelet volume ，platelet distribution width ，direct bilirubin ， hepatitis B e antigen and hepatitis B virus DNA more than 4×107 IU/mL had significant effect on interferon response （P＜0.05）. The accuracy ，specificity and area under characteristic curve of ANN test group were significantly higher than those of Logistic regression（P＜0.05）. CONCLUSIONS ：ANN model is accurate in predicting the efficacy of interferon in the treatment of CHB.关键词：Interferon;Chronic hepatitis B;Artificial neural network;Therapeutic efficacy;Prediction
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To com pare the efficacy and safety of 5 direct antiviral agents in the treatment of chronic hepatitis C infection as glecaprevir （GLE）/pibrentasvir（PIB），ledipasvir（LDV）/sofosbuvir（SOF），SOF/velpatasvir（VEL），elbasvir（EBR）/ grazoprevir（GZR）compound preparation and danoprevir （DNV）+ peginterferon combined with ribavirin （P/R）. METHODS ： Retrieved from PubMed ，Embase，Cochrane Library ，Web of Science ，CNKI，VIP，Wanfang database and other databases ，RCTs about 5 direct antiviral agents in the treatment of chronic hepatitis C infection were collected during the inception to Jun. 2020. After literature screening and data extraction ，the quality of included literatures were evaluated with bias risk evaluation tool recommended by Cochrane system evaluator manual 5.1.0. Meta-analysis was performed by using Stata 15.0 software. RESULTS ： A total of 48 RCTs with 12 227 patients in trial group were included. Results of Meta-analysis showed that the descending order of sustained virological response （SVR）rate was GLE/PIB ＞LDV/SOF＞SOF/VEL＞EBR/GZR＞DNV+P/R；weighted SVR rates of GLE/PIB，LDV/SOF，SOF/VEL and EBR/GZ were more than 95％. The incidence of any severe adverse event and adverse event in ascending order was EBR/GZR ＜GLE/PIB＜SOF/VEL＜LDV/SOF＜DNV+P/R. The incidence of nausea/vomiting in ascending order was GLE/PIB ＜LDV/SOF＜EBR/GZR＜SOF/VEL＜DNV+P/R. The incidence of rash in ascending order was LDV/SOF ＜ GLE/PIB＜SOF/VEL＜EBR/GZR＜DNV + P/R. The incidence of insomnia from low to high was GLE/PIB ＜EBR/GZR＜SOF/ VEL＜LDV/SOF＜DNV+P/R. CONCLUSIONS ：GLE/PIB，LDV/SOF，SOF/VEL and EBR/GZR have higher and similar effective rates in the treatment of chronic hepatitis C ，especially the weighted SVR rate of GLE/PIB is the best ，and the safety of EBR/GZR and GLE/PIB is relatively better.
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To provide referenc e for the construction and software development of knowledge base for rational use of TCM decoction pieces. METHODS ：By reviewing the literatures on rational drug use software and TCM decoction pieces in recent years ，the clinical characteristics of rational drug use of TCM decoction pieces as well as the characteristics and shortcomings of existing rational drug use software in the detection of rational drug use of TCM decoction pieces were analyzed ， and the core contents and difficulties in the construction of knowledge base of rational drug use software of TCM decoction pieces were summarized. RESULTS & CONCLUSIONS ：Clinical application of TCM decoction pieces was mainly based on “syndrome differentiation”，which reflected the unity of dialectics ，treatment，prescription selection and medication. Therefore ，the consideration of the rationality of clinical use of TCM decoction pieces could not blindly imitate the evaluation method of chemical medicine. Current rational drug use software was not based on the theoretical system of traditional Chinese medicine ，and it was not comprehensive and mature in the aspect of rational drug use review of TCM decoction pieces ，and lacks the knowledge base that could meet the requirements of rational use of TCM decoction pieces. Therefore ，it is necessary to construct a set of knowledge base which can meet the evaluation requirements of “consistency of principle ，method and prescription use ”of TCM decoction pieces under the guidance of TCM theoretical system. Its contents include that patient information collection ，construction of knowledge base related to diseases and syndromes ，selection of processed products of TCM dec oction pieces ，addition andsubtraction of clinical symptoms ，selection taboo of varieties of TCM decoction pieces ， compatibility taboo ， combined application of Chinese patent medicine or chemical medicine ， dosage of TCM decoction pieces ， total dosage and tastquantity of each prescription ， special de coction drugs ， medication methods and administration frequency ，etc. There are still some difficulties in the development of rational drug use software of TCM decoction pieces ，such as the construction of disease and syndrome related knowledge base and the difficulty in judging the rationality of clinical symptom addition and subtraction.
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发布时间：2022-06-21
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